Late-stage drug development company Paradigm Biopharmaceuticals Ltd (ASX: PAR) has reported ongoing positive data from patients who received Zilosul treatment under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).
Paradigm released its first set of data using the WOMAC pain scoring index in April 2020 after receiving feedback from the US FDA (Food and Drug Administration) during its pre-IND meeting that reduced WOMAC pain from baseline would be an acceptable endpoint for the company’s upcoming Phase 3 trials.
Data on the first 34 patients of this cohort returned a mean reduction in WOMAC pain of 44.9%. Data from a further 42 patients was released in October 2020, updating the mean reduction in WOMAC pain across 76 patients to 47.3%.
In the 89 patients treated with Zilosul, 75.3% reported at least a 25% reduction in WOMAC pain with 56.2% of patients reporting a greater than 50% reduction in WOMAC Pain.
Patients under the SAS programme treated across multiple sites have either failed standard of care and /or alternative therapies. Baseline WOMAC pain scores are recorded prior to commencing the six-week treatment programme where each patient receives 2mg/kg of Zilosul twice weekly.
SAS data has provided consistent evidence of clinically meaningful improvements in chronic pain. Clinically meaningful reduction of chronic pain has been defined to be between 25-30% pain reduction.
“It has been pleasing that as we have had additional patient data reported, we have seen consistent reduction in WOMAC pain with each group of patients with average WOMAC pain reduction across the 89-patient cohort being just under 50%,” Paradigm management stated.
“We are seeing consistent clinically meaningful reduction in pain and improvement in joint function in OA patients who have failed to respond to other medications.
“The focus for Paradigm is firmly on the IND submission this quarter and the initiation and recruitment of our PARA-008 and Pivotal Phase 3 trials.
“It is very important as Paradigm moves into its Pivotal Phase 3 clinical trial (PARA-002) that we are seeing real world evidence in subjects with knee OA responding in such a positive manner.”
The 89 patients [50 males, 38 females and 1 unknown with median age of 57.7 years (range 29 to 80 years)] had been clinically diagnosed with OA and subchondral BMLs. At the onset of PPS treatment patients were symptomatic with OA pain for at least six months and had failed current standard of care, which involved treatment with analgesics, NSAIDs (non-steroidal anti-inflammatory drugs) or corticosteroids.
Patients were administered with two injections of Zilosul per week for six weeks. (a total of 12 injections). Patients were followed up at six weeks following the last treatment. During PPS treatment, patients did not receive NSAIDs or corticosteroid treatment.
Paradigm Biopharmaceuticals LTD (ASX: PAR) is a late-stage drug development company with the mission to develop and commercialise Pentosan Polysulfate Sodium for the treatment of pain associated with musculoskeletal disorders driven by injury, inflammation, aging, degenerative disease, infection or genetic predisposition.